Aurobindo Pharma Ltd
Sterile Injectables,
Hyderabad.
Hyderabad.
Aurobindo Pharma Limited is a pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad, India. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients.
Job Title: Sr.Executive/Assistant manager/Deputy Manager
Job Description:
- Approval of Indented Raw Materials, Primary Packaging Materials and Secondary Packaging Materials as per the production plan.
- Coordination of the other departments in the batch planning and Ensure the Process flow, Personnel flow; Material flow shall be done as per the pre-defined procedures.
- To ensure the validation activity – qualification, requalification of area, equipment and facility.
- Close monitoring and regular trainings to the personnel involved in performing the aseptic area activity.
- Ensure the completion of activities like Batch Preparation, Product Filling, Lyo Loading, Lyo Monitoring, Unloading and Sealing.
- Ensures the proper training is being done to all the personnel regarding the Process, SOPs, Protocols before the start of the activity to avoid noncompliance during the activities.
- Handling and guiding the production personnel in closure of Change Controls, Incidents and Deviations
- Giving training on process related Sops, as per the schedule / Training Matrix.
- Updating cGMP related practices and recent regulatory up gradation to the personnel working in the shop floor to improve the systems. Self-inspection of cross functional department.
- To ensure the completion of all the observation of internal audits.
- As per the requirement manpower is assigned in the respective areas of work
- To ensure the minimum Inventory of spares and stock of chemicals to the Water System, WFI Plant, and PSG.
- Ensure the GMP and safety systems are followed strictly during the work execution.
- Responsible for final review of in-process and Finished product batches.
- Responsible for any other job assigned by Reporting Head.
Qualifications:
- Candidate should be with B.Pharm/M.Pharm/M.Sc and having rich experience of Minimum 8 to 12 Yrs. injectables.
- Should have strong technical knowledge.
- Minimum 2-3 US FDA audit exposure.
- Last 5 years MUST be sterile formulation manufacturing plant.